Segmental Laser Acupuncture for Constipation and Sleep in Patients With Parkinson's Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

TI-816-3E3 Portable Laser Phototherapy Device: Segmental laser acupuncture is administered using the TI-816-3E3 Portable Laser Phototherapy Device at the T10-L2 and S2-S4 regions. The device is applied in contact mode, with a power density of 100 mW/cm² and a treatment dose of 6 J/cm² per application. Each treatment session lasts 60 seconds. Treatment is administered twice weekly for 8 weeks.

TI-816-3E3 Portable Laser Phototherapy Device - Sham (0 J/cm²): Sham segmental laser acupuncture is administered using the TI-816-3E3 Portable Laser Phototherapy Device at the T10-L2 and S2-S4 regions. The device is applied in contact mode with a power density of 0 mW/cm² and a treatment dose of 0 J/cm² per application. The sham procedure provides visible light and is designed to be identical to the active treatment in terms of device operation, treatment procedure, treatment duration, and participants' sensory experience. Each treatment session lasts 60 seconds. Treatment is administered twice weekly for 8 weeks. No therapeutic laser energy is delivered.

Study summary

Parkinson's disease (PD) is characterized not only by motor symptoms but also by common and clinically significant non-motor symptoms, including constipation and sleep disturbances, which can substantially impair quality of life. The concept of the "gut-brain axis" describes bidirectional communication among the central nervous system, autonomic nervous system, enteric nervous system, and gut microbiota. Increasing evidence from animal models suggests that the gut-brain axis may play an important role in the pathophysiology and progression of PD.

Given the central role of autonomic nervous system regulation in the gut-brain axis, this study will use laser acupuncture as a safe, non-invasive form of photobiomodulation (PBM) with potential neuromodulatory effects. Based on the concept of segmental neuromodulation, laser stimulation will be applied to the thoracolumbar paraspinal regions (T10-L2) and sacral segments (S2-S4, corresponding to the Baliao points) to modulate sympathetic activity arising from T10-L2 and pelvic parasympathetic activity arising from S2-S4. This approach is intended to promote intestinal motility and defecation reflexes. Meanwhile, by modulating autonomic balance and stabilizing stress-sleep rhythms, as assessed by salivary biomarkers including salivary cortisol and salivary alpha-amylase (sAA), the intervention is expected to improve sleep quality in patients with PD.

This study is designed as a randomized, double-blind, sham-controlled clinical trial. Participants with PD who experience constipation will be recruited and undergo an 8-week intervention. The primary outcomes will assess changes in constipation symptoms using the Bristol Stool Form Scale (BSFS) and the Constipation Scoring System (CSS; Agachan Score). Secondary outcomes will assess sleep quality using the Parkinson's Disease Sleep Scale-2 (PDSS-2) and the REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). Objective salivary biomarkers, including salivary cortisol and sAA, will also be measured to investigate changes in autonomic function and their associations with improvements in clinical symptoms.

This study is expected to provide preliminary evidence regarding the potential role of segmental laser acupuncture in modulating the gut-brain axis and improving non-motor symptoms in patients with PD, thereby providing a basis for future larger-scale studies and the development of clinical care strategies.

Eligibility

Primary outcome measure(s)

• Change in Constipation Scoring System (CSS; Agachan score) — Week 0, Week 4, and Week 8
  Change in constipation severity assessed using the Constipation Scoring System (CSS; Agachan score). The CSS consists of 8 items assessing bowel movement frequency, difficulty, sensation of incomplete evacuation, abdominal pain, time spent on the toilet, and use of assistance for bowel evacuation. Scores range from 0 to 30, with higher scores indicating more severe constipation.
• Change in Bristol Stool Form Scale (BSFS) score — Week 0, Week 4, and Week 8
  Change in stool form assessed using the Bristol Stool Form Scale (BSFS), which classifies stool consistency into seven types ranging from hard stool to watery stool (Type1 to Type7).

Trial sites (1)

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